The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram

NCT00179257 | Completed Phase 3

• 1 other identifier: Lexapro Failure Study
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this is to determine the efficacy, safety, and tolerability of sertraline in patients with major depressive disorder (MDD) who have shown inadequate response ot escitalopram.

Conditions

Major Depressive Disorder

Keywords

Failure to Escitalopram

Outcome Measures

Primary Outcomes (3)

• Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)

• Hamilton Rating Scale for Depression (21-item) total score

• Clinical Global Impressions - Improvement Scale

Secondary Outcomes (2)

• Hamilton Anxiety Scale Total score

• Clinical Global Impressions - Severity Scale

Interventions

sertraline (Zoloft) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary DSM-IV diagnosis of Major Depressive episode of MDD without psychotic symptoms. Additional axis I diagnoses will be permitted only if they are identified as secondary diagnoses
• Ham-D 21 item score of greater than or equal to 18
• Age 18 and above
• Ability and willingness to provide consent for participation
• Failure to respond to escitalopram

You may not qualify if:

• Diagnosis of Bipolar Disorder or any psychotic disorder
• Alcohol or drug abuse or dependence currently or in the last 6 months
• A history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more
• Concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
• Use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep
• Use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of PRN use of diazepam 10 mg/day or its equivalent
• Presence of serious and/or unstable medical condition
• Score of 3 or 4 on the suicide item (item 3) of the Ham-D scale
• Known sensitivity of sertraline

Sponsors & Collaborators

• Vanderbilt University: lead
• Pfizer: collaborator

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Richard C Shelton, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Mood Disorders Clinic

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2004
• Study Completion: March 1, 2005
• Last Updated: June 2, 2015

Record last verified: 2015-06